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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219602
Company: GLENMARK SPECLT

Products on ANDA 219602

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219602

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219602

FLUTICASONE PROPIONATE

AEROSOL, METERED;INHALATION; 0.044MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLOVENT HFA	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB	021433	GLAXO GRP LTD
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	219602	GLENMARK SPECLT

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